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January 09, 2014

Should Risk of Death Always be Part of the Surgical Consent?

Ever since reports of alleged medical negligence came up in the case of 13 years old Jahi McMath who suffered cardiac arrest and subsequent brain death after a "routine" tonsillectomy that occurred Dec 9, 2013, the question has come up whether risk of death should become part of every single surgical procedure's informed consent no matter how rare that risk might be.

It also brings up the question whether patients would want to hear every single possible conceivable risk that may occur (which could ALWAYS include some infinitesimal risk of death) with even simple surgical procedure like ear tube placement for chronic ear infections.

[Disclaimer... I am not a lawyer and this is not legal advice.]

From the physician's perspective, Duke surgeons have thought about this quandary and here were their suggestions of what is considered "reasonable" when it comes to risk of death and the consent process:

• When the risk of death (or other complication) is so low as to be unexpected and highly improbable, including it as part of the consent may actually be misleading (may cause a patient not to pursue a needed surgical procedure due to unreasonable concern for a remote risk of death)
• When the risk of death (or other complication) is felt to be “high enough” to disclose, then this adverse outcome should be discussed among the risks, and the patient must be informed.
• How high should the risk of death (or other complication) be before one would want to include it as part of the consent process? This risk could be any chance at all to about 0.1% risk as a reasonable threshold.

From the patient's perspective, when it at least comes to anesthesia risks with children (which also has a remote risk of death), researchers were able to provide some numbers when it comes to consent (these numbers could also apply to other rare complications besides death):

• 87% of parents wanted to know the risk of death as a result of anesthesia. 13% did not.
• 68% of parents knew that risk of death was "extremely rare." 19% believed that risk of death occurs "once in a while," and 13% thought there was "no chance."
• 74% of parents wanted to know "all possible risks," 24% wanted to know only "those that are likely to occur," and 2% wanted to know only about those that would "result in significant injury."
• Mothers were more likely to want to hear all possible risks, whereas fathers were more likely to want to know only about those that are likely to occur.

Although media reports stated that Jahi underwent a "routine" tonsillectomy, that was actually not true. She underwent a UPPP surgery which is much more aggressive throat surgery than tonsillectomy alone. The reported risk of death with UPPP is around 0.2%. As such, disclosure of possible low risk of death would have been not unreasonable.

The risk of death for routine tonsillectomy is somewhere between 0.003% to 0.01%.

Just for comparison, the risk of dying from driving a car for over 50 years is 1.1% and annual risk of death from smoking 10 cigarettes per day is 0.5%. [Link] Note that these "mundane" risks of driving and smoking are higher than the risk of death associated with tonsillectomy or UPPP.

In the end, there is no set policy about when risk of death should be discussed. This disclosure has been left up to individual surgeons who use their professional judgement when that risk becomes large enough to merit discussion as part of the informed consent.

Dr. Christopher Chang is a private practice otolaryngology, head & neck surgeon specializing in the treatment of problems related to the ear, nose, and throat. Located in Warrenton, VA about 45 minutes west of Washington DC, he also provides inhalant allergy testing/treatment, hearing tests, and dispenses hearing aids. He is also the chief medical officer of O2Labz, a medical and scientific 3D animation company.Google+ Christopher Chang, MD Bio

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